NCT06528704

Brief Summary

During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
May 2024Dec 2026

Study Start

First participant enrolled

May 20, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

May 22, 2024

Last Update Submit

January 13, 2025

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

  • Delivered ventilation frequency

    Measured ventilation frequency (with or without ventilation feedback)

    2 minutes

  • Delivered ventilation volume

    Measured ventilation volume (with or without ventilation feedback)

    2 minutes

Study Arms (1)

Ventilation feedback

EXPERIMENTAL

First, ventilation without feedback, hereafter ventilation with feedback

Device: Ventilation feedback device

Interventions

Ventilation feedback deviceDEVICE

Device showing delivered ventilation frequency and volume.

Ventilation feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Traumatic cardiac arrest Inability to intubate patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Zeno

Knokke, West-Vlaanderen, 8301, Belgium

NOT YET RECRUITING

Ghent University Hospital

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Maxim Vanwulpen, MD

CONTACT

09 332 21 11maxim.vanwulpen@uzgent.be

Said Hachimi-Idrissi, MD

CONTACT

09 332 21 11

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

July 30, 2024

Study Start

May 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)